Cancer Cell Therapy – Process Development Associate (Onsite, 100% FTE)
The Stanford Center for Cancer Cell Therapy (CCT) is seeking a Process Development Associate (PD1) to perform process development consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.
This recruitment is for up to two (2) full time positions.
Manufacturing/PD Duties include*:
- Plan and perform components of process development and technology transfer for manufacturing of clinical cell therapies, scale-up/scale-out and optimization activities in transitioning and translating pre-clinical, benchtop research into phase appropriate clinical trials. This includes testing and process optimization at the small scale and in closed-system cell manufacturing platforms and novel gene editing technologies.
- Perform experiments in lab under the supervision and guidance of a manager.
- Knowledge and following SOPs and batch records preferred.
- Perform upstream and downstream components of assigned PD project(s).
- Keep an accurate documentation for all projects; including accurate laboratory notebook.
- Make recommendations on the research design and direction.
- Offer suggestions regarding process and Standard Operating Procedures (SOP) improvements.
- Help with general lab maintenance as needed; maintain lab stock, manage inventory and safety records, and provide general lab support as needed.
- Help orient and train new staff and/or students.
- Review literature on an ongoing basis to remain current with new procedures and related research.
- May contribute to the preparation and submission of abstracts or papers for publication in peer-reviewed journals and/or presentation at scientific conferences. Present results during internal meetings.
*- Other duties may also be assigned.
DESIRED QUALIFICATIONS:
- Experience with CAR T, TCR, T cells, gene editing, and cell therapy process development/manufacturing desired.
- Aseptic technique experience and cell culture preferred.
- cGMP experience is preferred.
- Knowledge and following SOPs and batch records preferred.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field or an equivalent combination of education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- General understanding of biological scientific principles.
- Aseptic technique and mammalian cell culture experience.
- General understanding on how to use laboratory equipment: biosafety cabinet, centrifuge, incubator, cell counter, micropipettes, etc.
- General understanding of current Good Manufacturing Practice (cGMP) guidelines.
- Computer skills and ability to learn quickly and master computer programs, databases and scientific applications.
- Strong attention to detail.
- Ability to work following Standard Operating Procedures (SOPs).
- Ability to work in a cleanroom space donning special sterile gowning.
- Ability to work under deadlines with minimal supervision.
- Ability to maintain relationships and communicate effectively between multiple functional groups.
- Excellent organizational skills and demonstrated ability to complete detailed work.
PHYSICAL REQUIREMENTS*:
- Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.
*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORKING CONDITIONS:
- May require working in close proximity to blood borne pathogens.
- Ability to work with unpredictable manufacturing schedules.
- Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
- Position requires working in a cGMP clean room environment.
- Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
- Position may work with human embryonic stem cells (hESCs).
- Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
- May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/ Chemicals, and confined spaces.
- May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.
WORK STANDARDS:
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
